Kornimate/medical-research-clean huggingface dataset:
a phase 3 study of bibp diphtheria, tetanus and acellular pertussis (three components) combined vaccine, adsorbed

Conditions: Whooping Cough; Diphtheria; Tetanus

Summary: the study will evaluate the safety, immunogenicity，immune persistence and lot-to-lot consistency of diphtheria,tetanus and acellular pertussis (three components) combined vaccine, adsorbed, (dtacp) including 2 parts: part 1 will evaluate the safety and immunogenicity of dtacp in health infants aged 2 months and 3 months compared with an adsorption tetanus-diphtheria-acellular pertussis (dtap) vaccine and diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and haemophilus influenzae type b conjugate vaccine (pentaxim)，compare the safety and immunogenicity of dtacp with different immunization schedules, and observe the immune persistence. part 2 will evaluate the lot-to-lot consistency of dtacp in health infants aged 3 months with the 3-dose schedule of 3-4-5 month.


Eligibility criteria:
inclusion criteria: * healthy subjects aged 2months (60-89 days) and 3months (90-119 days) ； * willing to provide proof of identity * subjects aged 2 months have not been vaccinated with dtap, ipv, hib, or 13-valent pneumococcal polysaccharide conjugate vaccine; * subjects of 3 months have not been inoculated with dtap vaccine, and ipv (only group a3）； * subjects'guardians or trustees are able to understand and sign the informed consent voluntarily, comply with the requirements of the clinical study plan. exclusion criteria: * with temperature \>37.0°c on axillary setting before vacciation; * with a medical history of diphtheria, pertussis or tetanus; * had contact with individuals with confirmed pertussis, diphtheria and tetanus diseases in their families in the past 30 days; * premature birth (delivery before the 37th week of pregnancy)or low birth weight (birth weight\< \<2500g); * history of dystocia, suffocation rescue, neurological damage; * with congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc. * history of epilepsy, convulsions or convulsions, or have a family history of mental illness; * history of abnormal blood coagulation (such as coagulation factor deficiency, coagulopathy); * had received immune enhancement or inhibitor therapy (continuous oral or instillation for more than 14 days); * history of severe allergic reactions to vaccination, such as difficulty breathing, urticaria; * any prior administration of blood products in last 3 month; * any prior administration of attenuated live vaccine in last 14 days; * any prior administration of subunit or inactivated vaccines in last 7 days; * plans to participate in or is participating in any other drug clinical study; * has any other factors judged by investigators that make them unfit to participate in the clinical trial
the effectiveness of diabetes patient education and self-management education in persons with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the goal of this randomized controlled trial is to determine if greater effectiveness can be achieved by the addition of lay-led self-management patient education to regular professionally-led diabetes patient education in comparison to regular professionally-led diabetes patient education only.

in the current health care environment, it is unacceptable for patient education programs to merely provide information. rather, educational programs must concentrate on behavior change and on supporting patients to become more confident and motivated in participating in managing their health. persons with type 2 diabetes attending a diabetes education centre will be assigned to either a group that receives regular professionally-led diabetes patient education (control group) or to to a group that receives regular professionally-led diabetes patient education augmented by lay-led self-management education i.e., the stanford six-session chronic disease self-management program (experimental group). data will be collected at two points in time (0 and 6 months). outcome measures will show if participants who receive self-management training in addition to regular patient education are able to:manage their diabetes more effectively; engage in the specific behaviors that keep the condition from worsening; achieve more control over their condition; and use the health care system more effectively.

Eligibility criteria:
inclusion criteria: * adults with type 2 diabetes exclusion criteria: * cognitive impairment * unable to speak english

Keywords: self-efficacy health behavior patient education health education
efficacy of two therapeutic techniques for the treatment of acromioclavicular dislocations

Conditions: Acromioclavicular Joint Dislocation

Summary: the aim of this study is to compare two therapeutical procedures for the grade iii acromioclavicular dislocations, either open reduction and internal fixation with a coracoclavicular device (minar-storz ) or non operative treatment. for these purpose we have designed an interventional, prospective, parallel assignment, opened and randomized study.

acromioclavicular dislocations are one of the most frequent traumatic lesions of the scapular girdle. they represent the 40-50% of the sport related shoulder injuries. there are different grades of dislocations being classified by altman- rockwood in 6 types. there is consensus for non operative treatment in types 1 and 2 and for surgical treatment in types 4, 5 and 6. for type 3 both therapeutic techniques are accepted with no high scientific evidence studies supporting either of them. during de 70's, surgical treatment was recommended for all these lesions but in the early 90´s surgeons´s preferences changed into the non-operative treatment. now a day, treatment is decided according to the surgeon experience and the functional demands of the patient. the aim of this study is to compare the results of non-operative treatment and open reduction and internal fixation with a coracoclavicular reconstruction device (minar-storz) in grade iii acromioclavicular dislocations.

Eligibility criteria:
inclusion criteria: * age between 18 and 50 years. * grade iii acromioclavicular dislocation. * signed informed consent. exclusion criteria: * any condition that may impair the functional recovery or the patient collaboration with the rehabilitation program (cognitive disability, neurological pathology, tumoral disease...). * previous acromioclavicular osteoarthritis. * previous acromioclavicular lesions. * concomitant lesions in the ipsilateral limb or in the contralateral shoulder. * polytraumatized patients. * any disease or condition the investigator finds decisive for exclusion.

Keywords: conservative treatment surgical acromioclavicular joint dislocation
japan morning surge-1 study

Conditions: Hypertension

Summary: the purpose of this study is to examine whether strict blood pressure (bp) control by doxazosin using home bp monitoring, especially targeting the morning bp level, can reduce hypertensive target organ damage.

morning blood pressure may play an important role in the pathogenesis of hypertensive target organ damage. increased sympathetic nerve activity is reported to be one of the mechanisms of morning hypertension; however, there are no available data that show whether strict home blood pressure control, especially in the morning period, can reduce target organ damage.we will evaluate whether strict morning blood pressure control by sympathetic nervous system blockade using an alfa-blocker, doxazosin, and with the addition of a beta-blocker if needed, can reduce hypertensive target organ damage.

Eligibility criteria:
inclusion criteria: * morning systolic blood pressure \>135 mmhg in a sitting position at home while on stable antihypertensive medication for at least 3 months exclusion criteria: * history of heart failure * presence of orthostatic hypotension, dementia, malignancy and chronic inflammatory disease * taking an alfa-blocker or beta-blocker * atrial fibrillation or atrial flutter

Keywords: morning hypertension
an observational study to assess the effectiveness and safety of a cemiplimab in adult patients with advanced non-small cell lung cancer (nsclc) in routine clinical practice settings in europe

Conditions: Non-small Cell Lung Cancer

Summary: this study is focused on patients with non-small cell lung cancer (nsclc) and have been prescribed a cemiplimab (libtayo®) based treatment regimen under standard care. the goal of this study is to learn more about the use, benefits, and safety of cemiplimab based treatment regimens in participants with nsclc.

originally registered as obs17104 by sanofi; transitioned to regn 05jul2023. the recruitment period will be 48 months. data will be collected during routine clinical visits approximately every three months while the patient is on cemiplimab treatment and then approximately every six months for up to 24 months after cemiplimab discontinuation. patients will be followed from cemiplimab treatment initiation until death, loss to follow-up, study withdrawal, or to the end of the study period (72 months after study launch), whichever occurs first.

Eligibility criteria:
key inclusion criteria: 1. at least 18 years of age at the time of cemiplimab treatment initiation 2. has been diagnosed with histologically or cytologically documented squamous or non-squamous nsclc 3. prescribed a cemiplimab-based regimen as part of routine clinical practice as determined by the treating physician per standard of care and in accordance with the summary of product characteristics (smpc). 4. can understand and complete the study-related questionnaires 5. must be legally capable of providing written consent for participation in the study and have signed informed consent prior to any study activities key exclusion criteria: 1. has received cemiplimab prior to enrollment 2. has uncontrolled autoimmune disease 3. has a contraindication to cemiplimab as noted in the local smpc 4. is concurrently participating in any other study of an investigational drug or procedure 5. has cognitive impairment or other medical condition that, in the opinion of the investigator, would interfere with the ability to complete the study-related questionnaires note: other protocol-defined inclusion/exclusion criteria apply
do pharyngeal packs during orthognathic surgery reduce postoperative nausea and vomiting

Conditions: Nausea; Vomiting

Summary: the purpose of this study is to determine whether pharyngeal packs can reduce nausea and vomiting in patients undergoing orthognathic surgery.

post-operative nausea and vomiting (ponv) is one of the most frequent and distressing complications of anesthesia. patients often rate that ponv is worse than postoperative pain. ponv alone is one of the leading causes for delayed discharge and unpleasant experiments. although ponv is not always life-threatening, persistent cases can result in dehydration, esophageal rupture, aspiration and potential death. the massive ingested blood and the additional issue of an altered diet (full liquids) due to a short period of jaw immobilization may be associated with a higher prevalence of ponv after orthognathic surgeries. although most of antiemetic drugs can help prevent ponv, they cannot preclude vomiting resulting from irritating gastrointestinal stimuli such as blood in the stomach. pharyngeal packs are thought to prevent the ingestion and aspiration of blood, cartilage and bone fragments during oral and maxillofacial surgeries. whether pharyngeal packs can reduce the incidence of ponv is controversial. it is reported that pharyngeal packs are recommended for the purpose of preventing ponv in nasal surgeries. however, some authors suggest that pharyngeal packs have no impact on ponv or the prevalence of ponv is doubled during routine nasal surgeries. however, the population size in these studies is relatively small and the trials have significant methodological weakness. none of these trials totally addressed the issue of the pharyngeal packs on the ponv following nasal surgeries. moreover, these studies include different types of nasal surgeries, not all of which can be assumed to have equivalent bleeding potential. orthognathic surgeries performed maxillary and mandibular osteotomies and are assumed to involve massive blood loss. orofacial swelling and swallowing blood is common in the early postoperative period after orthognathic surgeries. whether pharyngeal packs can reduce the swallowing blood and ponv is unknown. thus, the objective of this study is to determine whether pharyngeal packs can reduce nausea and vomiting in patients undergoing orthognathic surgery.

Eligibility criteria:
inclusion criteria: * undergoing elective orthognathic surgery * age 18-50 year olds * signed informed consent exclusion criteria: * pregnant women * past history of oesophageal surgery, oesophageal varices or stricture, * patients who have received antiemetic medication in the 24 hours before surgery * emergency surgery * prior history of motion sickness and/or ponv, vertigo or migraine headaches

Keywords: pharyngeal pack nausea vomiting orthognathic surgery maxillary osteotomy
cognitive behavioural therapy for persons with mci or mild dementia

Conditions: Alzheimers' Disease

Summary: a total of 200 home dwelling participants, who fulfil the inclusion criteria, alzheimer's disease, will be recruited from three hospitals in norway. the intervention is based on a standardized manual, and consists of 11 weekly one-hour sessions, which are organized into six thematic modules. the content of each session is specified by a treatment manual, which additionally consists of worksheets, suggestions for homework in between sessions and letters to the caregivers (the german manual: werheid \& thöne-otto, 2010; the norwegian manual: ulstein, gordner \& tonga, not published). the treatment will be conducted by experienced health staff (nurses, psychologist, doctors) with formal training in cognitive behavioural therapy, and knowledge about alzheimer's disease. furthermore, the health staff will be familiarised with the manual before study inception, participate in a two-day training seminar and will regularly be supervised. the control condition will be offered treatment as usual at the participating the memory clinics. the hypothesis is that the participants in the intervention group will report less depression and increased self efficacy as compared with the control group. we conducted a pilot study with 10 patients, 5 in each group, from march to june 2013 to examine the feasibility of the study protocol and do want to include these patients in the study population.


Eligibility criteria:
inclusion criteria: a diagnosis of dementia (alzheimers disease or mixed alzheimer and vascular dementia) within the past twelve months, consistent with the icd-10. mini mental examination score of twenty or above cornell depression scale score of five or above a career who is willing to participate in the interventions, as this is part of the treatment programme. a carer is here defined as the main person responsible for the informal care for the patient and who has regular weekly contact with the patient. exclusion criteria: severe somatic or psychiatric comorbid diagnoses, including alcohol and substance abuse, that would impair their cooperation in the intervention programme dementia with lewy bodies and frontotemporal dementia, as the intervention is considered to be too cognitively challenging for these patients poor command of norwegian ongoing psychotherapy -

Keywords: alzheimers' disease cognitive behavioral therapy depression self-efficacy quality of life
post-market study evaluating the safety and effectiveness of nunec® cervical arthroplasty system

Conditions: Cervical Intervertebral Disc Degeneration

Summary: the objective of this study is to evaluate long-term safety and effectiveness of the nunec® cervical arthroplasty system in a small patient population. the nunec device is currently ce marked and commercially available in europe.

the nunec® feasibility study is a prospective, multi-centered, non-randomized clinical trial. only patients who have been diagnosed with single level, c3 to c7, symptomatic cervical degenerative disc disease and have failed at least 6 weeks of conservative treatment or present signs of progression of spinal cord/nerve root compression with continued non-operative care will be enrolled. patients will be evaluated preoperatively and postoperatively at discharge, 6 weeks, 3, 6, 12 and 24 months.

Eligibility criteria:
inclusion criteria: * is at least 21 years of age and skeletally mature * must have symptomatic degenerative disc disease at one level in the cervical spine, c3 to c7, demonstrated by herniated disc and/or spondylosis; * must have completed a minimum of six weeks of unsuccessful conservative, non-operative care or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of conservative treatment * must score at least 15/50 (30%) on the neck disability index * is willing and able to follow the post-operative management program * must understand and sign the informed consent document exclusion criteria: * symptomatic cervical ddd at more than one level * axial neck pain as the primary diagnosis without evidence of neural compression * neck or arm pain of unknown etiology * any significant anatomical consideration which would make the anterior cervical approach excessively risky or impossible * severe spondylosis at the target level * prior surgery at the target level * fused level adjacent to the target level * osteoporosis, osteopenia, osteomalacia, paget's disease or metabolic bone disease * active infection or surgical site infection * is using any medication known to interfere with bone/soft tissue healing * diabetes mellitus requiring daily insulin management * any terminal, systemic, or autoimmune disease * medical conditions or mental incompetence which may interfere with study requirements * bmi \>40 or a weight more than 100 lbs over ideal body weight * chemical dependency problem that may interfere with study requirements * current smokers * history of any invasive malignancy unless treated and in remission for at least two years * documented allergies to metal or plastic * currently pregnant, or interested in becoming pregnant during the study follow-up

Keywords: total disc replacement
therapeutic effect of chang'an i recipe on irritable bowel syndrome with diarrhea

Conditions: Irritable Bowel Syndrome With Diarrhea

Summary: to evaluate the efficacy and safety of tcm decoction chang'an i recipe in the treatment of ibs-d. a multicenter, randomized, double-blind, placebo-controlled clinical trial was designed. patients were applied for central random number and were given corresponding treatment according to inclusion sequences.the treatment group was administered the chang'an i recipe, 150ml/bag, 3 times/day; while the control group was administered the placebo, 150ml/bag, 3 times/day. both courses of treatment were 8 weeks.


Eligibility criteria:
inclusion criteria: * patients meeting the diagnostic criteria of western medicine for ibs-d; * aged 18-70 years old; with a baseline ibs-sss score over 75 points; * voluntarily signed the informed consent; * local resident who could ensure follow-ups, with basic reading ability. exclusion criteria: * patients with ibs-c, -m, and uncertain forms; * accompanied with serious lesions in major organs including heart, liver, and kidney, hematopoietic system diseases, and tumors; * gastrointestinal organic disease (e.g., chronic pancreatitis), or systemic diseases affecting the digestive tract motion (e.g., hyperthyroidism, diabetes, chronic renal insufficiency, and nervous system diseases); * undergoing or requiring constant use of drugs that may affect gastrointestinal functions (e.g., anti-cholinergic drugs, calcium channel blockers, 5-ht3 receptor antagonist, antidiarrheal agents, antacids, prokinetic agents, antidepressants, anxiolytics, and intestinal flora regulating drugs); * with history of abdominal surgery (e.g., cholecystectomy); * with an allergy history of tested drugs or severe allergy history of food; * pregnant and lactating female; * with a history of neurological or psychiatric disorders; * or participating in other clinical trial.

Keywords: ibs-d; chang'an i recipe; placebo
capturing brca1/2 mutational status in women with high grade serous ovarian cancer and impact on clinical outcome.

Conditions: Ovarian Cancer

Summary: brca1 or brca2 genes, are implicated in 10-15% of ovarian cancer cases, increased to 22% germline brca1/2 mutation frequency in patients with high grade serous histology subtype, including those women who have no family history of breast or ovarian cancer. with the rapid advancement of therapeutics targeted this population, this protocol seeks to provide genetic brca1/2 screening to all patients with high grade serous ovarian cancer. this information may help in selection of future treatment options and genetic testing for brca1/2 may be used to potentially prevent a proportion of cancer for the family members. this study will be an opportunity for patient to improve access at genetic and molecular testing for brca1/2 mutation which could impact her future treatment option. moreover, this study will allow to prospectively assess the proportion of patients with brca mutation in ovarian cancer and describe the type of mutations identified in a large population.

primary objectives · to provide genomic profiling for brca1 and brca2 mutational status in patients' with high grade serous ovarian cancer. secondary objectives * to track the number of women with high grade serous ovarian cancer who are being screened in princess margaret cancer center for mutations in brca1/2 * to track accrual rates and clinical outcomes in patients with high grade serous ovarian cancer who are brca1/2-positive * to correlate impact of brca1/2 mutational status on clinical outcome * to track utilization of genetic counseling services at princess margaret cancer centre

Eligibility criteria:
inclusion criteria: * patients with high grade serous carcinoma originating from the ovaries, fallopian tube or peritoneal cavity; subtype of high grade endometrioid and clear cell ovarian cancer could be eligible in the exploratory cohort * patient must be ≥18 years old * all patients must have sufficient archival tumor tissue for molecular analysis * all patients must consent to have a genetic testing * all patients must have signed and dated an informed consent form exclusion criteria: · other histology subtype

Keywords: brca1/2 mutational status